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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K112982
Device Name ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )
Applicant
Small Bone Innovations, Inc.
1380 S. Pennsylvania Ave.
Morrisville,  PA  19067
Applicant Contact JOHN MINIER
Correspondent
Small Bone Innovations, Inc.
1380 S. Pennsylvania Ave.
Morrisville,  PA  19067
Correspondent Contact JOHN MINIER
Regulation Number888.3020
Classification Product Code
HSB  
Date Received10/06/2011
Decision Date 04/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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